Yoga Fatigue Study
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|ClinicalTrials.gov Identifier: NCT02134782|
Recruitment Status : Recruiting
First Posted : May 9, 2014
Last Update Posted : March 17, 2021
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia (AML) Acute Lymphocytic Leukemia in Relapse Burkitt's Lymphoma Stage III Burkitt's Lymphoma Stage IV Type 3 Diffuse Large B-Cell Lymphoma||Behavioral: Individualized Yoga Intervention Group Other: iPad Activity Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Controlled Trial of Individualized Yoga to Reduce Fatigue in Hospitalized Children Receiving Intensive Chemotherapy|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2023|
|Estimated Study Completion Date :||October 2023|
Experimental: Individualized Yoga Intervention Group
Yoga will be administered individually by a trained yoga instructor, and offered daily for 21 days (5 days per week or 15 days in total). There will be a common structure for all sessions that will include relaxation and breathing exercises. Additional poses focused on strength, flexibility, and balance will be incorporated at low, moderate or high intensity levels based upon the wishes and abilities of the child and parent and the judgment of the yoga instructor. The target intensity will be documented and may change with each yoga session. Each yoga session will vary in duration between 15 and 45 minutes. Modifications will be made to accommodate devices such as central venous lines, particularly if accessed. For children who are in isolation, the research team will follow hospital policies and procedures.
Behavioral: Individualized Yoga Intervention Group
These children will not receive a study-supplied iPad. Use of child or hospital supplied iPad games, music, movies or books will be permitted without any modification, encouragement or discouragement of these activities. There will be no restrictions on concomitant medications. Standardized sleep hygiene recommendations will be provided.
Active Comparator: iPad Activity Control Group
For those randomized to the control group, visits by the same yoga instructors will occur at the same schedule as the yoga intervention. Contact will be offered daily (5 days per week) for 21 days. The yoga instructor will offer games, music, movies or books on a study-supplied iPad. The instructor will offer to interact with the child (for example, read to, or play games with the child) for a maximum of 45 minutes (the maximum length of yoga sessions). This approach will allow us to control for contact frequency and the individual providing contact, and consequently, to better measure the independent effect of yoga. These children will not receive yoga during the 3 week iPad activity period; instructors will receive specific training to ensure that no yoga occurs during this time frame. Use of child or hospital supplied iPad activities will be permitted instead of the study-supplied iPad activities.
Other: iPad Activity Control Group
These children will not receive yoga during the 3 week iPad activity period; instructors will receive specific training to ensure that no yoga occurs during this time frame. Use of child or hospital supplied iPad activities will be permitted instead of the study-supplied iPad activities. There will be no restrictions on concomitant medications. Standardized sleep hygiene recommendations will be provided.
- Change in proxy-reported general fatigue (PedsQL MFS) [ Time Frame: Change from baseline to day 10 and day 21 ]The primary outcome is parent/guardian proxy-reported general fatigue using the pediatric population validated questionnaire PedsQL Multidimensional Fatigue Scale (MFS) measured at day 21. PedsQL MFS assesses general fatigue, sleep/rest fatigue and cognitive fatigue. The investigators have chosen this fatigue measure as the primary outcome as in our experience, it is sensitive to change and it is easy to administer and complete.
- Change in proxy-reported other fatigue outcomes (PedsQL MFS) [ Time Frame: Change from baseline to day 10 and day 21 ]One of the secondary outcomes is the other fatigue outcomes for proxy-reported PedsQL MFS (sleep/rest fatigue and cognitive fatigue) on days 10 and 21.
- Change in proxy-reported fatigue outcomes (FS-P) [ Time Frame: Change from baseline to day 10 and day 21 ]One of the secondary outcomes is the Fatigue Scale Parent (FS-P) on days 10 and 21.
- Change in proxy-reported fatigue outcomes (PedsQL Acute Cancer Module) [ Time Frame: Change from baseline to day 10 and day 21 ]One of the secondary outcomes is the fatigue outcomes for proxy-reported PedsQL Acute Cancer Module (pain, nausea and anxiety) on days 10 and 21.
- Use of systemic opioids [ Time Frame: Change from baseline to day 21 ]All systemic opioid administrations between randomization and date off study will be tabulated and will be expressed as the cumulative amount in morphine equivalents/kg/day on study. Systemic opioid administration will be obtained from patient's chart review. Systemic opioid intake is o potential co-variates the could affect fatigue.
- Change in self-reported fatigue [ Time Frame: Change from baseline to day 10 and day 21 ]Patient self-reported fatigue using the scales PedsQL MFS (Child and adolescent versions) and FS-Adolescent and FS-Child, are exploratory endpoints.
- Change in self-reported quality of life [ Time Frame: Change from baseline to day 10 and day 21 ]Patient self-reported quality of life using the scale PedsQL Acute Cancer Module (child and adolescent version) is another exploratory endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134782
|Contact: Lillian Sung, MDfirstname.lastname@example.org|
|United States, Connecticut|
|Connecticut Children's Medical Center||Recruiting|
|Hartford, Connecticut, United States, 06106|
|Contact: Andrea Orsey, MD, MSCE Aorsey@connecticutchildrens.org|
|Principal Investigator: Andrea Orsey, MD, MSCE|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N 4V8|
|Contact: Nicole Culos-Reed, PhD 4032207540 email@example.com|
|Principal Investigator: Nicole Culos-Reed, PhD|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Principal Investigator:||Lillian Sung, MD||The Hospital for Sick Children|